BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED PRECOAT TIBIAL PLATE

    MDR report key: 3940581 · Received June 25, 2014

    Report

    Report Number
    2648920-2014-00160
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    April 19, 2011
    Report Date
    December 16, 2013
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED; THE CONDITION OF THE COMPONENTS IS UNKNOWN. PRIMARY AND REVISION OP NOTES WERE RECEIVED. NO ISSUES WERE NOTED FROM THE PRIMARY OP NOTES. REVISION OP NOTES IDENTIFIED THAT THE ARTICULAR SURFACE WAS NOTED TO BE IN GOOD CONDITION. THE TIBIAL COMPONENT WAS REMOVED AND THE CEMENT-COMPONENT INTERFACE WAS NOTED TO BE INTACT. MICRO MOVEMENT WAS IDENTIFIED UNDER THE TIBIAL TRAY AT THE BONE-CEMENT INTERFACE. NO X-RAYS WERE PROVIDED; IT IS UNKNOWN IF THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION CODES: THE DEVICE HISTORY RECORDS FOR THE TIBIAL PLATE AND BONE CEMENT WERE REVIEWED AND FOUND TO BE CONFORMING, INDICATING THE DEVICES WERE MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. THE INFORMATION PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT NUMBER 1822565-2014-00057.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369731 NEXGEN STEMMED PRECOAT TIBIAL PLATE JWH ZIMMER 60674836

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention LOT #65884131, MANUFACTURED AT HERAEUS MEDICAL AND| CATALOG #00111314001, PALACOS R+G BONE CEMENT| DISTRIBUTED BY (B)(4).